Sulfacetamide (Topical)

(sul fa SEE ta mide)

Acne: Topical: Klaron lotion, topical suspension: Apply thin film to affected area twice daily

Bacterial infections: Topical:

Cream, Ovace Plus lotion: Apply to affected areas twice daily for 8 to 10 days.

Foam: Apply to affected areas 1 to 3 times daily

Wash: Apply to affected areas 1 to 2 times daily for 8 to 10 days.

Scaling dermatoses: Topical:

Cream, Ovace Plus lotion: Apply to affected areas twice daily for 8 to 10 days. Dosing interval may be lengthened as eruption subsides. Applications once or twice weekly, or every other week may be used for prevention. If treatment needs to be reinitiated, start therapy as a twice-daily regimen.

Foam: Apply to affected areas 1 to 3 times daily

Shampoo: Wash hair at least twice weekly.

Wash:

Ovace Plus Wash Liquid, Ovace Plus Wash cleansing gel, Ovace wash: Wash affected areas twice with a 10- to 20-second interval between washings; repeat twice daily for 8 to 10 days. Dosing interval may be lengthened as eruption subsides. Applications once or twice weekly, or every other week may be used for prevention. If treatment needs to be reinitiated, start therapy as a twice-daily regimen.

SEB-Prev: Wash affected areas twice daily for 8 to 10 days. Dosing interval may be lengthened as eruption subsides. Applications once or twice weekly, or every other week may be used for prevention. If treatment needs to be reinitiated, start therapy as a twice-daily regimen.

Topical: Avoid contact with eyes and mucous membranes.

Foam: Cleanse affected skin thoroughly and pat dry before each application. Shake well prior to use. Dispense into palm of hand. Massage into affected areas and wait 10 minutes; rinse thoroughly with water and pat dry.

Lotion, topical suspension: Shake well prior to use.

Shampoo: Apply to wet hair and massage vigorously into scalp; thoroughly rinse hair.

Wash: Apply to wet skin and massage into a full lather, rinse thoroughly with plain water, and pat dry. If skin dryness occurs, rinse off early or use less frequently. When used for scaling dermatitis, regular shampooing after use is not necessary; however, hair should be shampooed at least once weekly.

Concerns related to adverse effects:

• Autoimmune effects: Fatalities associated with severe reactions, including drug-induced systemic lupus erythematosus, have occurred with sulfonamides (regardless of administration route).

• Blood dyscrasias: Fatalities associated with severe reactions, including agranulocytosis, acute hemolytic anemia, aplastic anemia, purpura hemorrhagica, and other blood dyscrasias, have occurred with sulfonamides (regardless of route).

• Dermatologic reactions: Fatalities associated with severe reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug fever, have occurred with sulfonamides (regardless of route). In addition, contact dermatitis, reddening, and scaling of the skin may occur.

• Hepatic effects: Fatalities associated with severe reactions, including fulminant hepatic necrosis and jaundice, have occurred with sulfonamides (regardless of route).

• Hypersensitivity reactions: Skin rash or other reactions have occurred in patients with no prior history of sulfonamide hypersensitivity. Discontinue use at the first sign of hypersensitivity or rash.

• Sulfonamide (“sulfa”) allergy: Traditionally, concerns for cross-reactivity have extended to all compounds containing the sulfonamide structure (SO2NH2). An expanded understanding of allergic mechanisms indicates cross-reactivity between antibiotic sulfonamides and nonantibiotic sulfonamides may not occur, or at the very least this potential is extremely low (Brackett 2004; Johnson 2005; Slatore 2004; Tornero 2004). In particular, mechanisms of cross-reaction due to antibody production (anaphylaxis) are unlikely to occur with nonantibiotic sulfonamides and antibiotic sulfonamides. A nonantibiotic sulfonamide compound which contains the arylamine structure and therefore may cross-react with antibiotic sulfonamides is sulfasalazine (Zawodniak 2010). T-cell-mediated (type IV) reactions (eg, maculopapular rash) are less understood and it is not possible to completely exclude this potential based on current insights. In cases where prior reactions were severe (Stevens-Johnson syndrome/TEN), some clinicians choose to avoid exposure to these classes.

• Systemic effects: Systemic absorption is increased with application to large, infected, abraded, denuded, or burned skin.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer’s labeling.

Other warnings/precautions:

• Appropriate use: For external use only; not for ophthalmic use; avoid contact with eyes and mucous membranes. Discontinue use if irritation, rash, or signs of hypersensitivity occur. Monitor closely for local irritation and/or sensitization during long-term therapy.

• Infection: Application to infected area containing nonsusceptible organisms may cause proliferation of the organism.

• Metabisulfites: Some products contain sodium metabisulfite which may cause allergic reactions in certain individuals (eg, asthmatic patients).

• Other topical products: Not compatible with silver-containing products.

The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, based on sulfonamides acting as a competitive inhibitor of para-aminobenzoic acid (PABA) utilization, an essential component for bacterial growth. While absorption through intact skin in humans has not been determined, in vitro studies with human cadaver skin indicated a percutaneous absorption of about 4%. Sulfacetamide sodium is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine largely unchanged. The biological half-life has been reported to be between 7 to 13 hours.

The pharmacokinetics of sulfacetamide and its major metabolite sulfanilamide in Sulfacetamide Sodium Topical Suspension USP, 10% was evaluated in adult subjects (N=14) with acne vulgaris. The subjects applied Sulfacetamide Sodium Topical Suspension USP, 10% to their face, back, chest and shoulders every 12 hours for 28 days. The percentage of the applied dose of Sulfacetamide Sodium Topical Suspension USP, 10% excreted in the urine as sulfacetamide plus sulfanilamide, ranged from 0.08 to 0.33%.

In controlled clinical trials for the management of acne vulgaris, the occurrence of adverse reactions associated with the use of Sulfacetamide Sodium Topical Suspension USP, 10% was infrequent and restricted to local events. The total incidence of adverse reactions reported in these studies was less than 2%. Only one of 105 patients treated with Sulfacetamide Sodium Topical Suspension USP, 10% had local adverse reactions of erythema, itching and edema. It has been reported that sulfacetamide sodium may cause local irritation, stinging and burning. While the irritation may be transient, occasionally, the use of the medication has to be discontinued.